I first wrote about the Innovative Licensing and Access Pathway (ILAP) in 2021 shortly after it had initially been published on the Medicines and Healthcare products Regulatory Agency (MHRA) website. In a series of short blogs I shall unpack what is involved and what we have learnt so far.
To recap: ILAP is a pathway that enables fresh and creative approaches to the development of medicines with the aim of improving patient access. These medicines can be New Chemical Entities (NCEs), biologicals, new indications or repurposed products. It aims to increase the possibilities for improved regulatory and other stakeholder collaboration.
Since the inception of ILAP the three original main partners (MHRA, National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC)) have been recently joined by the All Wales Therapeutics and Toxicology Centre (AWTTC). The supporting partners remain the same: NHS England and NHS Improvement, the Health Research Authority (HRA) and the National Institute for Health Research (NIHR).
ILAP comprises of:
- an Innovation Passport (IP) designation – the first step of ILAP
- a Target Development Profile (TDP)
- access to a Toolkit to support all phases of the design, development and assessment procedure for applicants
The Innovation Passport (IP)
To gain an IP you must fulfil each of the following:
Criteria 1: Details of the condition, patient or public health area
Criteria 2: The medicinal product fulfils one or more of a specific area
Criteria 3: The medicinal product has the potential to offer benefits to patients
The ILAP Innovation Passport blog goes into further details.
ILAP allows entry very early in the development process, based on non-clinical data, where all the tools in the TDP Toolkit might be options. ILAP also caters for medicines with mid-development dossiers.
Useful tip: To maximise the benefits of ILAP, applicants are encouraged to apply early in the development of their products.
The Target Development Profile (TDP)
A product-specific team of experts will help define the Target Development Profile based on your product’s characteristics. The TDP will:
- define key regulatory and development features
- identify potential pitfalls
- create a road map for delivering early patient access
The TDP should be a living document, revised over the length of the development programme as fresh knowledge is gained. It will include details on how to collaborate with other UK stakeholders for coordinated and efficient evidence generation and evaluation.
The Target Development Profile blog goes into further details.
The TDP toolkit
The Toolkit involves many implements to assist development and mirrors a life cycle approach to evidence generation, together with aspects to ensure regulatory compliance.
The ILAP TDP Toolkit blog goes into further details.
Useful tip: ILAP does not replace the Promising Innovative Medicine Designation of the Early Access to Medicines Scheme (EAMS) and you can apply for both initiatives.
- Innovation Passport: £3,624
- Initial Target Development Profile: £4,451
Look out for my other ILAP-related blogs in this series…
Fusion Pharma have experience in this area. If you would like to discuss how Fusion Pharma can support you with ILAP, please email us at email@example.com or phone us on +44 (0) 203 1379 799.
While the information in this article is considered to be true and correct at the date of publication, changes in guidance and/or experience may impact on the accuracy of the information. Please refer to the relevant guidance for the latest information.